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NCT03977233 · ClinicalTrials.gov registry record · Phase 2

Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer

A Phase 2 study of Pancreatic Neoplasms and Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by UNC Lineberger Comprehensive Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
45
Enrollment target
1
Study location

NCT03977233 is a Phase 2 study of Pancreatic Neoplasms and Pancreatic Ductal Adenocarcinoma (PDAC) that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 600-participant average among 30 other Pancreatic Neoplasms trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03977233, a Phase 2 study of Pancreatic Neoplasms and Pancreatic Ductal Adenocarcinoma (PDAC), is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
45 participants
Enrollment target
1
Study location

Study Summary

This is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed). However, not all types of PDACs are resectable, especially if they are close to important structures like blood vessels or intestines. These types of PDACs are treated with chemotherapy such as FOLFIRINOX. Research studies showed that chemotherapy after surgical resection of PDAC tumors reduced the risk of the cancer returning. Chemotherapy is used to treat PDAC that has not spread outside of the pancreas and is not resectable. FOLFIRINOX is a chemotherapy treatment that combines multiple chemotherapeutic agents, including oxaliplatin, leucovorin, irinotecan, and 5-FU. Patients receive these agents by intravenous infusion. Of these drugs, 5-FU requires you to return home with a chemotherapy pump that will deliver chemotherapy over 46 hours. This regimen has been studied in pancreatic cancer that has been removed with surgery as a method for preventing the cancer from returning. Studies showed FOLFIRINOX chemotherapy reduced the risk of cancer returning and increased patients survival. In this study, researchers want to know if FOLFIRINOX chemotherapy given before surgery will make the cancer easier to remove with surgery and increase the chances of the cancer staying away after surgery. Researchers have shown that pancreatic cancers are not all the same when you look at the DNA and RNA that is inside a pancreatic cancer cell. Depending on the expression of different genes in a cancer cell, some pancreatic cancers may respond differently to chemotherapy. In this study researchers want to know if FOLFIRINOX chemotherapy can change the genetic profile of the cancer. This will be studied by obtaining a biopsy of the cancer before the start of chemotherapy, and after 8 treatments of ch

Conditions Studied

Pancreatic Neoplasms Pancreatic Ductal Adenocarcinoma (PDAC) Pancreas Adenocarcinoma Cancer of Pancreas Pancreatic Cancer Non-resectable Pancreatic Cancer, Adult Pancreatic Cancer Resectable

Interventions

  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG Irinotecan Hydrochloride
  • DRUG 5-FU

Study Locations (1)

North Carolina

  • University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center - Chapel Hill

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2019-06-12
Est. Completion 2030-01
Phase Phase 2

Sponsor

UNC Lineberger Comprehensive Cancer Center

366 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03977233

The ClinicalTrials.gov registry entry for NCT03977233 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 600-participant average among 30 other Pancreatic Neoplasms trials with a reported enrollment target (92% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Pancreatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Leucovorin is the first listed.

NCT03977233 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT03977233 about?

NCT03977233 is a clinical study titled "Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer". This is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed). However, not...

What is the current status of trial NCT03977233?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2019-06-12. Estimated completion is 2030-01.

What conditions does trial NCT03977233 study?

This clinical trial studies the following conditions: Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreas Adenocarcinoma, Cancer of Pancreas, Pancreatic Cancer Non-resectable.

What interventions are being tested in trial NCT03977233?

The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan Hydrochloride (DRUG), 5-FU (DRUG).

Who is sponsoring clinical trial NCT03977233?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03977233 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.